The Tissue Fixation System: How obsolete and potentially dangerous technology continues to be ‘sold’

Abstract

Gynaecologists have been at the receiving end of much regulatory intervention in recent years, some of it inappropriate and heavy-handed such as the recent ban on midurethral slings in the National Health Service, others appropriate and, if anything, occurring too late. Regulatory agencies have failed, and so have individual doctors and their organisations. An example of individual and systemic failure involves the Tissue Fixation System. It is an Australian story that is not yet widely known, which is why the author has decided to acquaint the readers of ANZJOG with the situation in this country, where the Tissue Fixation System was invented, manufactured and used on thousands of patients over a period of eight years before its manufacture, sale and export from Australia ended in 2014.